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Model Number M00562422 |
Device Problems
Electrical /Electronic Property Problem (1198); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-00494 for the associated device information.It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the physician was trying to remove a polyp while the device was connected to a generator.When operating the generator, they mentioned that it generates energy intermittently and it was not able to cut through the polyp.They also attempted to use the device without the use of cautery.Another snare was opened however the same problem was noticed.The procedure was completed using a third captiflex snare.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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